NovoSeven RT
Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Pakuotės lapelis
(PIL)
31-05-2024
Prekės savybės
(SPC)
31-05-2024
Veiklioji medžiaga:
Eptacog alfa (activated); Histidine
Prieinama:
Novo Nordisk Pharmaceuticals Pty Ltd
Klasė:
Medicine Registered
Pakuotės lapelis
NovoSeven
®
RT
page 1 of 5
NovoSeven RT-cmi4.doc
NOVOSEVEN
®
RT
1.0MG, 2.0MG, 5.0MG AND 8.0MG
eptacog alfa (activated) (bhk)
Recombinant coagulation factor VIIa
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT NOVOSEVEN
®
RT IS USED FOR ... 1
BEFORE YOU USE NOVOSEVEN
®
RT ...... 1
USING NOVOSEVEN
®
RT ..................... 2
WHILE YOU ARE USING NOVOSEVEN
®
RT
........................................................... 2
SIDE EFFECTS ........................................ 2
STORAGE .............................................. 2
PRODUCT DESCRIPTION ......................... 3
NOVOSEVEN
®
RT USER INSTRUCTIONS . 4
This leaflet answers some common
questions about NovoSeven
®
RT. It
does not contain all the available
information. It does not take the place
of talking to your doctor or healthcare
professional.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using NovoSeven
®
RT against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
HEALTHCARE PROFESSIONAL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOVOSEVEN
®
RT IS
USED FOR
NovoSeven
®
RT is a medicine that
works by activating the blood clotting
system at the site of bleeding. It is
similar to the activated factor VII (7) in
human blood. NovoSeven
®
RT is made
by genetic engineering.
NovoSeven
®
RT is used to control
bleeding episodes and to prevent
excessive bleeding connected with
surgery in people who have;
inhibitors to clotting factors
VIII (8) or IX (9), or
congenital FVII deficiency,
Glanzmann’s Thrombasthenia
which cannot be treated
effectively with platelet
transfusions.
Your doctor may want to give you
NovoSeven
®
RT for another reason.
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Prekės savybės
Product Information
NovoSeven RT-pi4.doc
Page 1 of 13
PRODUCT INFORMATION
NOVOSEVEN
RT
NAME OF THE MEDICINE
Recombinant Coagulation Factor VIIa (rFVIIa)
eptacog alfa (activated) (bhk)
CAS number: 102786-61-8
DESCRIPTION
NovoSeven
RT contains activated recombinant coagulation Factor VII of
approximate
molecular mass 50K Daltons produced by genetic engineering from baby
hamster kidney
cells (BHK cells). The recombinant coagulation Factor VIIa (rFVIIa)
in NovoSeven RT is
structurally very similar to human plasma-derived activated Factor
VIIa.
NovoSeven RT is supplied as a stable, sterile, freeze-dried white
powder in single-use vials.
After reconstitution with solvent, each vial contains rFVIIa
1.0mg/mL (50,000 IU/mL),
sodium chloride 2.3mg/mL, calcium chloride dihydrate 1.5mg/mL,
glycylglycine 1.3mg/mL,
polysorbate 80 0.1mg/mL and mannitol 25mg/mL, sucrose 10mg/mL,
methionine 0.5mg/mL
and histidine 1.6mg/mL.
The units of rFVIIa are international units measured with reference
to the first international
standard of FVIIa 89/688. These units should not be mistaken for
units of other coagulation
factors including FVII.
PHARMACOLOGY
PHARMACODYNAMICS
The role of FVIIa in the induction of haemostasis includes the direct
activation of FIX into
FIXa and
FX into FXa following the binding of FVIIa to exposed Tissue Factor,
initiating the
conversion of prothrombin into thrombin. Thrombin leads to the
activation of platelets and
Factors V and VIII at the site of injury and the formation of a
haemostatic plug by converting
fibrinogen into fibrin.
Pharmacological doses of NovoSeven RT activates FX directly on the
surface of activated
platelets at the local site of injury, independently of Tissue
Factor. This results in the
conversion of prothrombin into large amounts of thrombin, independent
of Tissue Factor.
Accordingly, the pharmacodynamic effect of FVIIa gives rise to an
increased local
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